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FDA 510(k)

ASSUFIL

K-Number: K021767 · 2002-11-19

ApplicantAssut Europe S.P.A.
Decision Date2002-11-19
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ASSUFIL is the device name listed in this FDA 510(k) record. The listed applicant is Assut Europe S.P.A.. It received FDA 510(k) clearance on 2002-11-19 under 510(k) number K021767. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSUFIL?

ASSUFIL is a medical device that received FDA 510(k) clearance on 2002-11-19. The listed applicant is Assut Europe S.P.A.. The 510(k) number is K021767.

When did ASSUFIL receive FDA 510(k) clearance?

ASSUFIL received FDA 510(k) clearance on 2002-11-19, under 510(k) number K021767.

Who is the listed applicant for ASSUFIL?

The FDA 510(k) record lists Assut Europe S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASSUFIL?

The FDA product code for ASSUFIL is GAM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Assut Europe S.P.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171039Assut Filbloc Permanent Sutures

Related Devices (Code: GAM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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